Cosmo Pharmaceuticals N.V. / Key word(s): Agreement
04-Oct-2022 / 06:00 GMT/BST
Release of an ad hoc announcement pursuant to Art. 53 LR
The issuer is solely responsible for the content of this announcement.
Ad hoc announcement pursuant to Art. 53 LR
Dublin, Ireland & Heppenheim, Germany – 04 October 2022: Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) and InfectoPharm today announced the signing of a License and Distribution Agreement for Winlevi® (clascoterone) cream 1% in Germany, Italy and Austria.
Under the terms of the agreement, Infectopharm will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi® in Germany, Italy and Austria. Cosmo is responsible for the centralized procedure before the European Medicines Agency (EMA) aimed at obtaining a single Marketing Authorization for the product in the European Union and will be the exclusive supplier of same product. Cassiopea will receive an upfront payment of Euro 1 million, potential regulatory milestones totaling up to Euro 4.5 million and customary double-digit royalties on net sales.
Winlevi® has been approved by the United States Food & Drug Administration (FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older. It is the first in class topical androgen receptor inhibitor that tackles the androgen hormone component of acne and is the first new mechanism of action in acne approved by the FDA in 40 years. Winlevi® was launched in the US in November 2021 by Sun Pharma and is already the most prescribed branded topical acne drug in the US based on IQVIA data. About 11,000 US physicians have prescribed Winlevi® to date. According to the prescriptions generated, Winlevi® has been one of the most successful US launches in the topical acne space in the last 15 years.
InfectoPharm is a well-established family-owned German company which operates internationally and enjoys high reputation among physicians, especially pediatricians and dermatologists. With sales of Euro 50 million, the dermatological range is an important pillar of the business. InfectoPharm is an experienced player in the field of acne. With Winlevi® InfectoPharm will complement its acne portfolio. As the first player in the European market, InfectoPharm sees a high potential of Winlevi® to become a game changer in the treatment of acne and thus provides a great benefit for patients.
Diana Harbort, President of Cosmo’s Dermatology Division, said: “We are very pleased to further grow Winlevi® franchise and partner with InfectoPharm, a company with strong expertise in the acne market in the selected countries. We look forward to making Winlevi® available to an ever larger number of patients once EU regulatory approval has been granted. The excellent performance of Winlevi® in the US provides a strong opportunity to expand the business to other geographic territories around the world.”
Dr. Markus Rudolph, Managing Director of InfectoPharm commented: “We are very happy to partner with Cosmo and to enter a trustful and reliable partnership. Winlevi® with its new mode of action will be a perfect match to complete our acne portfolio. We are sure Winlevi® will be a significant change in the acne therapy and we are proud to introduce this topical acne drug in Europe. We are confident to continue the success story of the US and bring innovation in acne therapy to Europe.”
End of Inside Information
|Company:||Cosmo Pharmaceuticals N.V.|
|Riverside 2, Sir John Rogerson’s|
|Dublin 2 Dublin|
|Phone:||+ 353 1 817 0370|
|Listed:||SIX Swiss Exchange|
|EQS News ID:||1455793|
|End of Announcement||EQS News Service|